Universal catheter anchoring system

ABSTRACT

A method of securing a medical article to the body of a patient is disclosed in which an anchoring device comprising an anchor and a retainer is used. The retainer is attached to an upper surface of the anchor and comprises a base, a cover and a post. The base is disposed on the upper surface of the anchor and the cover is connected to the base so as to move between an open and a closed position. When the cover is in the closed position, it lies above at least part of the base. The post is attached movably to either the base or the cover and is arranged so as to lie at least partially between the cover and the base when the cover is in the closed position. When securing a medical article, the cover is placed in the open position and the medical article placed onto the retainer. The cover may then be closed over the medical article and the anchoring device attached to the patient.

RELATED CASES

This application is a continuation of U.S. patent application Ser. No.09/897,717, filed on Jun. 29, 2001, issued as U.S. Pat. No. 6,770,055 onAug. 3, 2004, which is a continuation-in-part of U.S. patent applicationSer. No. 09/513,054, filed on Feb. 24, 2000, issued as U.S. Pat. No.6,582,403 on Jun. 24, 2003 and also claims priority under 35 U.S.C.§119(e) from Provisional Application No. 60/215,100 filed on Jun. 29,2000, entitled “IMPROVEMENTS TO UNIVERSAL CATHETER ANCHORING DEVICE,”all of which are hereby expressly incorporated by reference in theirentireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates in general to a universal anchoring systemfor securing a medical article to a patient and, in particular, to auniversal anchoring system for securing a catheter to a patient toinhibit movement or migration of the catheter relative to the patient.

2. Description of Related Art

It is common in the treatment of patients to utilize catheters tointroduce fluids and medications directly into the patient or towithdraw fluids from the patient. An example of a typical catheter is acentral venous catheter, or CVC, which is used to introduce fluidsthrough a central vein.

In most cases, the catheter remains in place for many days. In order tosecure the catheter in position at the insertion site, a healthcareworker often secures the catheter to the patient using tape. That is,the healthcare worker commonly places long pieces of tape across theportion of the catheter near the insertion site in a crisscross patternto secure the catheter to the patient's skin. This securement inhibitsdisconnection between the catheter and the insertion site, and alsoprevents the catheter from snagging on the bed rail or other objects.

Tape, however, often collects dirt and other contaminates. Normalprotocol therefore requires periodic (e.g., daily) tape changes toinhibit bacteria and germ growth at the securement site. These frequenttape changes often excoriate the patient's skin. Additionally, valuabletime is spent by healthcare workers applying and reapplying the tape.Because many healthcare workers find the taping procedure cumbersome anddifficult to accomplish when wearing gloves, they often remove theirgloves when taping. Not only does this increase the amount of time spenton the taping procedure, but it also subjects the healthcare worker toan increased risk of infection. Moreover, even if healthcare workersremain gloved, contact between the adhesive surface of the tape and thelatex gloves can cause micro-holes in the gloves, subjecting thehealthcare worker to possible infection.

A variety of catheter securement devices have been developed to obviatethe need for frequent application of tape to secure a catheter to apatient. One such securement device provides a flexible clamp withwinged extensions that are sutured to the patient's skin. In someapplications, the winged extensions are integrally formed with catheter.In other applications, the flexible clamp is covered by a rigid fitting,which receives the catheter/clamp combination in a friction-fit manner.The rigid fitting and flexible clamp are formed with lateral, alignedholes, which allow the combination to be sutured to the patient's skin.Although these suturing devices securely attach the catheter to thepatient, it is obviously painful and uncomfortable for the patient.These devices are also time consuming and inconvenient to secure, posethe risk of needle-stick to the health care provider, and risksuture-site infection to the patient.

In addition, suture material tends to exhibit poor gripping on medicaltubes and can cut through the winged extension of the flexible clamp ifa rigid clamp is not used. However, the use of a rigid fittingcomplicates the securement procedure by adding yet another componentthat can be dropped on the floor and become unsterile. In addition, thesutured securement of the flexible clamp and/or the rigid fittingassembly does not permit easy release of the catheter from the patientfor dressing changes and insertion site cleaning. A removal instrument(e.g., sterile scissors) also is generally required for suture removal.

Rather than suturing lateral, aligned holes to a patient's skin, othercatheter securement devices provide an adhesive layer or resilient bandinterposed between the flexible clamp and the patient's skin. See, forexample, U.S. Pat. Nos. 5,342,317; 5,192,274; 5,084,026; 4,449,975; and4,250,880. Many of these securement devices, however, suffer from one ormore of the following disadvantages: are time consuming and inconvenientto secure; have multiple parts, which can be dropped and become nonesterile; and require removal instruments (e.g., hemostat or scissors) todisengage the catheter from the securement device.

Additionally, no standard exists regarding spacing of the lateral holesof the catheters and catheter fittings. Manufacturers invariably producecatheters and catheter fittings with holes having varying geometries anddistances therebetween. Prior securement devices thus become dedicatedto fit and secure only certain catheters.

SUMMARY OF THE INVENTION

The present invention provides a simply-structured anchoring system thatsecures a catheter in a fixed position, but easily releases the catheterfor dressing changes or other servicing. The present invention alsorecognizes that prior art catheter anchoring systems have been dedicatedto a particular catheter, catheter fitting or catheter manufacturer.Thus, the present anchoring system also can cooperate with the suture ormounting holes of many different catheter and catheter fitting designs.In particular, the present anchoring system can be adjusted so as to beused with a variety of catheters and/or catheter fittings which havevarying distances between the suture or mounting holes of the catheterand/or fitting. The present invention also provides a technique foranchoring medical articles to a patient in a fixed position and allowingfor the release of those articles.

One aspect of the present invention involves an anchoring system forsecuring a medical article to the body of a patient. The anchoringsystem comprises an anchor pad having an upper surface and a lowersurface. At least a portion of the lower surface has an adhesive surfaceto attach the anchor pad to the body of the patient. A retainer ismounted on the upper surface of the anchor pad and is capable ofreceiving a portion of the medical article. The retainer includes abase, a cover, and a post. The base is disposed on the upper surface ofthe anchor pad and the cover is movable connected to the base so as tomove between an open position and a closed position. The cover liesabove at least part of the base when in the closed position. The post ismovably coupled to one of the base and the cover and is arranged on theretainer so as to at least partially lie between the cover and the basewhen the cover is in the closed position.

In accordance with another aspect of the present invention, an anchoringsystem is provided for securing a medical article to the body of apatient. The anchoring system comprises an anchor pad having an uppersurface and a lower surface. At least a portion of the lower surface hasan adhesive surface to attach the anchor pad to the body of the patient.A retainer is mounted on the upper surface of the anchor pad and iscapable of receiving a portion of the medical article. The retainerincludes a base, a post, and a cover assembly. The cover assemblyincludes including at least two covers, each cover being connected tothe base by a hinge mechanism. Each cover being movable between at leasttwo positions: an open position and a closed position. The post iscoupled to one of the base and covers and is arranged on the retainer soas to at least partially lie between the base and at least one of thecovers when the cover is in the closed position.

One aspect of the present invention accordingly involves an anchoringsystem for securing a medical article to the body of a patient. Theanchoring system comprises an anchor pad, a retainer, and a postsubassembly. The retainer is mounted on the upper surface of the anchorpad and includes a base, a cover assembly, and a latching mechanism. Thebase receives the medical article to be secured, and the cover assemblycan be moved between an open and a closed position. In the openposition, the medical article can be inserted or removed from theretainer. In the closed position, a channel is formed within which themedical article is held securely. The latching mechanism operatesbetween the base and the cover assembly to hold it in the closedposition. The post subassembly includes a number of posts that protrudeinto the channel of the retainer and interact with the medical articleto prevent any inadvertent motion.

In one preferred mode, the post subassembly includes posts that aremovable with respect to the base of the retainer and to each other, soas to accommodate mounting or suture hole spacings of various distances.In another mode, the post subassembly includes posts that are fixedrelative to the base.

In a preferred mode, the cover assembly of the retainer is divided intotwo separate covers which are independently latched to the base andwhich can independently be adjusted between the open and closedpositions.

In accordance with each of the aspects of the invention summarizedabove, the anchoring system can also include a fitting. The fitting canbe part of the medical line itself or can be a separate component thatcan be attached to the medical line. For example, in one mode, themedical article can be a catheter with an integral fitting. The fittingcan also be a removable fitting (e.g., a movable wing clamp) that isreleasably attached to the catheter. As such, these components cancomprise an anchoring system kit, where one or more sizes of fittingsare included in the kit in order to accommodate catheters of differingsizes.

In accordance with another aspect of the invention, a method foranchoring a medical article using an anchoring device is presented. Theanchoring device has an anchor and a retainer. The retainer has a baseand at least one cover. A post is disposed either upon the base or thecover and when the cover is moved into a closed position, the post liesat least partially between the cover and the base. When securing amedical article, the cover is placed in an open position, a portion of amedical article is placed within the base, and then the cover is closedto engage the retainer with the medical article and the anchoring devicemay then be secured to the patient.

In accordance with a further aspect of the method, the anchor may be ananchor pad with an adhesive surface which is attached to the skin of apatient and upon which the retainer is mounted.

In accordance with another further aspect of the method, a second postmay be provided on the retainer of the anchoring device.

In another further aspect of the method, a second cover may be providedon the anchoring device.

In accordance with another aspect of the method described above, a lowersupport member may be provided which lies between the base of theretainer of the anchoring device and the anchor.

In a further aspect of the method, the lower support member may beformed unitarily with the base of the retainer.

Further aspects, features and advantages of the present invention willbecome apparent from the detailed description of the preferredembodiments that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

The above mentioned and other features of the invention will now bedescribed with reference to the drawings of a preferred embodiment ofthe present anchoring system. The illustrated embodiment of theanchoring system is intended to illustrate, but not to limit theinvention. The drawings contain the following figures:

FIG. 1 is a perspective view of an anchoring system in accordance with apreferred embodiment of the present invention including a pair ofmovable posts and a pair of separate covers illustrated in an openposition and with a corner of an anchor pad turned up to illustrate itslower surface;

FIG. 2 is a perspective view of the anchoring system of FIG. 1 shownwith the covers in a closed position;

FIG. 3 is a perspective view of the anchoring system of FIG. 1illustrated with the covers in the open position and an exemplarycatheter illustrated by phantom lines in an inserted position within theretainer;

FIG. 4 is a perspective view of the anchoring system of FIG. 3 shownwith the covers in the closed position and the exemplary catheter (againshown in phantom lines) positioned in and retained by the retainer;

FIG. 5 is a top plan view of the base and covers of the retainer of FIG.1 shown with one cover in the open position and one cover in the closedposition;

FIG. 6 is a cross sectional side view of the retainer of FIG. 5 takenalong line 6-6;

FIG. 7 is a front elevational view of the retainer of FIG. 5;

FIG. 8 is an enlarged view of the area encircled by line 8-8 of FIG. 5and illustrates the structure of a post opening within the base of theretainer;

FIG. 9 is a front elevational view of a post platform of the retainer ofFIG. 1;

FIG. 10 is a side elevational view of the post platform of FIG. 9;

FIG. 11 is a top plan view of the post platform of FIG. 9;

FIG. 11A is a top plan view of an alternate post platform for use withthe retainer of FIG. 1;

FIG. 11B is a front elevational view of the post platform of FIG. 11A;

FIG. 11C is a side elevational view of the post platform of FIG. 11A;

FIG. 12 is a top plan view of the assembled retainer of FIG. 1,including the base, covers and post platform, shown with an exemplarycatheter in the channel of the retainer and the covers in the openposition;

FIG. 13 is a front plan view of another post platform using fixedposition posts, suitable for use with the base and cover of FIG. 1;

FIG. 14 is a side elevational view of the fixed post platform of FIG.13;

FIG. 15 is a top plan view of the fixed post platform of FIG. 13;

FIG. 16 is a cross-sectional view of the fixed post platform of FIG. 15taken along line 16-16;

FIG. 17 is a bottom plan view of the assembled retainer of FIG. 1,showing the placement of the movable post platform of FIG. 9 within thegroove of the retainer base;

FIG. 18 is a bottom plan view of an assembled retainer using the fixedpost platform of FIG. 13 within the groove of the retainer base;

FIG. 19 is a perspective view of an anchoring system in accordance withan additional preferred embodiment of the present invention including afixed post and a movable post, with the cover in a closed position;

FIG. 20 is a perspective view of the anchoring system of FIG. 19 shownwith the cover in an open position;

FIG. 21 is an exploded perspective view of the retainer of FIG. 19,illustrating the movable post detached from the retainer;

FIG. 22 is a front elevational view of the retainer of FIG. 19, with thecover shown in a fully open position;

FIG. 23 is a top plan view of the retainer of FIG. 22, with the coverfully open;

FIG. 24 is a cross-sectional view of the retainer taken along line 24-24of FIG. 19 showing the movable post within a track of the retainer;

FIG. 25 is a perspective view of the movable post of FIG. 21;

FIG. 26 is a front plan view of the assembled retainer of FIG. 19 withthe cover shown in the closed position;

FIG. 27 is a top plan view of the retainer of FIG. 19 shown in the fullyopen position with an exemplary catheter shown inserted into the channelof the open retainer;

FIG. 28 is a perspective view of the anchoring system of FIG. 19 shownwith the cover in a partially open position and with an exemplarycatheter shown in phantom lines within the channel of the retainer;

FIG. 29 is a perspective view of the anchoring system of FIG. 28 shownwith the cover in a closed position;

FIG. 30 is a partial, perspective view of the latching mechanism of theretainer of FIG. 19 shown in a partially open position; and

FIG. 31 is a bottom plan view of the anchor pad, showing a releaseliner;

FIG. 32 is a top plan view of a unitary base and lower support memberfor an alternate retainer;

FIG. 33 is an inverted front elevational view of the unitary base andlower support member of FIG. 32;

FIG. 34 is a perspective view of the unitary base and lower supportmember of FIG. 32.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present embodiment of the catheter anchoring system, which isgenerally designated by reference numeral 10, is disclosed in thecontext of use with an exemplary CVC (as shown in FIG. 3 and designatedby reference numeral 12). The principles of the present invention,however, are not limited to catheters. Instead, it will be understood byone of ordinary skill in this art, in view of the present disclosure,that the anchoring system and/or retainer disclosed herein also can besuccessfully utilized in connection with other types of medicalarticles, including, but not limited to, other types of catheters, fluiddrainage and delivery tubes and electrical wires. For example, butwithout limitation, the retainer disclosed herein also can be configuredto receive and secure peripheral catheters, peripherally insertedcentral catheters, hemodialysis catheters, surgical drainage tubes,feeding tubes, chest tubes, nasogastric tubes, scopes, as well aselectrical wires or cables connected to external or implanted electronicdevices or sensors. One skilled in the art may also find additionalapplications for the devices and systems disclosed herein. Thus, theillustration and description of the anchoring system in connection witha CVC is merely exemplary of one possible application of the anchoringsystem.

Each of the embodiments described herein employs some basic conceptscharacteristic of the present anchoring system, namely releasableengagement of the catheter to the patient. The releasable engagement isachieved by cooperation among a base, at least one cover and at leastone post element. This cooperation allows the catheter to bedisconnected from the anchoring system and from the patient, for any ofa variety of known purposes. For instance, the healthcare worker maywant to remove the catheter from the anchoring system to easedisconnection of the catheter from the insertion point or to clean thepatient. The disengagement of the catheter from the anchoring system,however, can be accomplished without removing the anchoring system fromthe patient.

Common to each the described embodiments, the present anchoring systeminhibits axial movement of the catheter with respect to the anchoringsystem, and hence, with respect to the insertion site on the patient.Transverse and lateral movement is generally arrested by the holdingeffect provided by the base and cover assembly, as well as by thecooperative interaction between at least one post member and an openingon the catheter and/or catheter fitting. That is, the base and coverassembly surround the catheter while the post(s) extends through acorresponding suture or mount opening(s) formed on the catheter and/orcatheter fitting. Longitudinal movement is similarly arrested by theinteraction between the post(s) and the opening(s).

In one form, the present anchoring system also is adapted to receive atleast several different types or styles of catheters and/or catheterfittings. In particular, the spacing between the posts and/or thespacing between a post and either the cover assembly or base can bevaried in order to accommodate catheters and/or catheter fittings withdiffering spacings between the suture holes. This feature can also beused to accommodate catheters and/or catheter fittings having differentsizes and/or shapes. In one of the embodiments described below, theretainer includes two posts, each of which is movable with respect tothe other and also with respect to the cover assembly and the base ofthe retainer. In another embodiment, one of the posts is fixed and theother is movable. The spacing between the posts, as well as the spacingbetween the movable post and the adjacent base/cover structure, can bevaried by moving the one post. In other variations, the post(s) can befixed to a cover or base section which can move relative to anothersection of the retainer to changes the position of the post(s) on theretainer. So configured, the lateral width between posts can be adjustedto receive and secure a variety of catheters and/or catheter fittings.Various other aspects of the present invention, however, can be usedapart from this “universal” feature, as will be apparent from thediscussion of the embodiments below.

To assist in the description of these components of the anchoring system10 (see FIG. 3), the following coordinate terms are used. A“longitudinal axis” is generally parallel to the section of the catheter12 retained by the anchoring system 10. A “lateral axis” is normal tothe longitudinal axis and is generally parallel to the plane of theanchor pad 14. A “transverse axis” extends normal to both thelongitudinal and lateral axes. In addition, as used herein, “thelongitudinal direction” refers to a direction substantially parallel tothe longitudinal axis; “the lateral direction” refers to a directionsubstantially parallel to the lateral axis; and “the transversedirection” refers to a direction substantially parallel to thetransverse axis. Also, the terms “proximal” and “distal,” which are usedto describe the present anchoring system 10, are used consistently withthe description of the exemplary applications. Thus, proximal and distalare used in reference to the center of the patient's body. The terms“upper,” “lower,” “top,” “bottom,” and the like, which also are used todescribe the present anchoring system 10, are used in reference to theillustrations of the embodiments. A detailed description of theanchoring system 10, and its associated method of use, now follows.

Dual Cover Retainer System

With reference to FIGS. 1 and 2, the anchoring system 10 is constructedin accordance with a preferred embodiment of the present invention. Thesystem comprises an anchor pad 14 and a retainer 16 that includes a base18, a cover assembly 19 and at least one post. In the illustratedembodiment, the post is part of a post platform that is attached to theretainer base 18 when the retainer 16 is assembled. The post, as notedbelow, can be part of the base 18 and/or the cover assembly or be aseparate individual piece. The retainer 16 is configured to accept andto retain and secure a section of a catheter 12 (shown in FIG. 3) withinthe anchoring system 10. Alternatively, the same arrangement can be usedto secure a detachable catheter fitting which is attached to a catheterto be retained, as described below.

As illustrated in FIGS. 3 and 4, the catheter 12 or fitting is insertedinto the base 18 of the retainer 16 while the cover assembly 19 is in anopen position, as shown in FIG. 3. As illustrated, the cover assembly 19in the present embodiment comprises two separate covers 20, 22, eachindependently attached to the base 18. Once the catheter 12 or fittingis positioned on the base, the covers 20, 22 are moved into a closedposition over the base 18 and catheter 12 to inhibit transverse motionof the catheter 12. This can be seen in FIG. 4. The catheter 12 orfitting also is retained laterally and longitudinally by its interactionwith one or more posts of the retainer 16 and by its interaction withthe surrounding sections of the base 18 and/or the covers 20, 22.

The retainer 16 is disposed upon an upper surface of the anchor pad 14.The lower side 23 of the anchor pad 14 includes an adhesive surfacewhich adheres to the skin of the patient in order to maintain theposition of the retainer 16, and hence the catheter 12, with respect tothe patient.

As is seen in FIG. 1, the anchor pad 14 is a substantially flat piece ofmaterial with transversely opposing sides. The proximal or lower side 23of the pad faces toward the skin of the patient, and is preferablycovered with an adhesive surface suitable for attaching the anchor pad14 to the skin of the patient. The upper or distal side 24 of the padfaces away from the skin of the patient and supports the retainer 16.

The anchor pad 14 preferably comprises a laminate structure with anupper foam layer (e.g., closed-cell polyethylene foam) and a loweradhesive layer. The lower adhesive layer constitutes the lower surface23 of the anchor pad 14. The lower surface 23 desirably is amedical-grade adhesive and can be either diaphoretic or nondiaphoretic,depending upon the particular application. Such foam with an adhesivelayer is available commercially from Tyco Adhesives of Norwood, Mass.

A surface of the upper foam layer constitutes the upper surface 24 ofthe anchor pad 14. The upper surface 24 can be roughened by chemicalpriming or corona-treating the foam with a low electric charge. Theroughened or porous upper surface 24 can improve the quality of theadhesive joint (which is described below) between the base 18 and theanchor pad 14. In the alternative, the flexible anchor pad 14 cancomprise a medical-grade adhesive lower layer, an inner foam layer andan upper paper or other woven or nonwoven cloth layer.

A removable paper or plastic release liner 26 desirably covers theadhesive lower surface before use. The liner 26 preferably resiststearing and desirably is divided into a plurality of pieces to easeattachment of the pad to a patients skin. In the illustrated embodiment,the liner is split along a centerline 28 of the flexible anchor pad 14in order to expose only half of the adhesive lower surface at one time.

The length of each liner piece, as measured in the lateral direction,extends beyond the centerline 28 of the anchor pad 14 and is foldedover, or back onto the liner. This folded over portion defines apull-tab 30 to facilitate removal of the liner piece 26 from theadhesive lower surface. A healthcare worker uses the pull-tab 30 bygrasping and pulling on it so that the liner piece 26 is separated fromthe lower surface. The pull-tab eliminates the need to pick at a corneredge or other segment of the liner in order to separate the liner fromthe adhesive layer. The pull-tab 30 of course can be designed in avariety of configurations. For example, the pull-tab need not be locatedalong a centerline of the anchor pad 14; rather, the pull-tab can belocated along any line of the anchor pad 14 in order to ease theapplication of the anchor pad 14 onto the patient's skin at a specificsite. For example, an area of a patient's skin with an abrupt bend, suchas at a joint, can require that the pull-tab be aligned toward one ofthe lateral ends of the anchor pad 14 rather than along the centerline.

The anchor pad 14 also preferably includes a concave section 32 thatnarrows the center of the anchor pad 14 proximate to the retainer 16. Inthe illustrated embodiment of FIG. 2, the anchor pad 14 is formedgenerally into a crescent shape that includes a concave section 32 onone side of the retainer and a convex section 34 on the other. Thisshape permits the pad 14 to be placed on the patient such that the armsof the crescent extend away from the insertion site.

The retainer is preferably centered upon the anchor pad 14 about an axiswhich bifurcates the crescent shape. Consequently the lateral sides ofthe anchor pad 14 have more contact area, both forward and rearward ofthe retainer 16 in the longitudinal direction, which provides greaterstability and adhesion to a patient's skin while still permitting theretainer 16 to be located near the insertion site. Although notillustrated, the anchor pad 14 also can include suture and/or breatherholes to the sides of the retainer 16.

With reference now to FIGS. 5-8, the base 18 and the cover assembly 19principally define the retainer 16. As noted above, the cover assembly19, in the illustrated embodiment, comprises two covers 20, 22, each ofwhich is connected to the base at a folding hinge 36. This arrangementallows the base 18 and the covers 20, 22 to be formed as a unitarypiece. This can be accomplished by any of a variety of ways well knownto those skilled in the art. For instance, the base 18 and the coverassembly can be injection molded in order to reduce fabrication costs.As shown in FIG. 5, one cover 20 is in a closed position, while theother cover 22 is in an open position.

As will become apparent, several features of the cover assembly and base18 are desirably flexible. Suitable materials which are bothsufficiently strong but flexible include without limitation: plastics,polymers, or composites such as polypropylene, polyethylene,polycarbonate, polyvinylchloride, acrylonitrile butadiene styrene,styrene butadiene, nylon, olefin, acrylic, polyester, moldable silicon,thermoplastic urethane, thermoplastic elastomers, thermoset plastics andthe like. The retainer 16 is preferably formed by injection moldingusing a styrene butadiene polymer, such as KRO3 resin, availablecommercially from Phillips Petroleum of Houston, Tex. However, othermaterials can be used, and the retainer can comprise a multi-piece baseor cover as well.

In the embodiment illustrated in FIG. 5, the base 18 includes anelongated body of a generally hollow, generally parallelepiped shape.The base 18 can be configured in a variety of shapes, however, such ascircular, square, or trapezoidal, in order to suit a particularapplication. For example, the base 18 may be configured to generallymatch the shape of the anchor pad 14 (shown in FIG. 1) or the shape ofthe winged catheter fitting (not shown). In the illustrated embodiment,a parallelepiped shape is preferably used to allow the base 18 andcovers 20, 22 to be integrally formed and to capture the somewhatrectangular shape of the catheter fitting wings (see FIG. 12).

As understood from FIGS. 5-7, a bottom wall 37 of the base 18 includes asubstantially flat bottom surface 38 with the exception of a recess 40that extends upward. The recess 40 extends laterally from one lateralside of the base 18 to the other along the bottom side 38 of the base18, and has a longitudinal width and transverse depth sufficient toreceive the post(s) and/or a post platform, as described below.

The base 18 also includes one or more openings to facilitate connectionof the post(s) (described below) to the base 18. These holes extendthrough the bottom wall 37 of the base 18 and open into a hollowreceiving space 42 defined within the retainer 16. In the illustratedembodiment, a central circular opening 44 is formed in the center of therecess 40; however, this opening can be disposed at other locations onthe base 18.

As will be described in greater detail below, the retainer 16 includesat least one post, which in some modes of the invention is movablerelative to the base 18. The base 18 accordingly includes at least oneadditional opening to receive the post. This opening can have acomplementary shape to that of the post or can be enlarged relative toor have a different geometry than the shape of the post. In the mode ofthe invention where the post is movable, the opening desirably has ashape that is elongated in at least one direction so as to allow thepost to move in such direction.

In the embodiment illustrated in FIGS. 1-12, the base 18 includes twoadditional openings 46 to receive two posts. While only a single postand hence a single opening is required, the illustrated embodiment usestwo posts and two openings. Each post opening 46 is provided for acorresponding post such that the corresponding post protrudes throughthe bottom wall 37 of the base 18 when the retainer 16 is assembled. Theretainer 16, however, can include more than two post-opening pairings insome applications of the present anchoring system, as will be understoodby one of ordinary skill in the art.

As best seen in FIGS. 5 and 8, each post opening 46 in the illustratedembodiment includes a substantially circular region 48 and an elongatedslot 50 extending from the substantially circular region 48. Thesubstantially circular region 48 has a diameter larger than the width ofthe elongated slot 50, and the elongated slot 50 has a width larger thanthe diameter of the corresponding post.

The present embodiment is configured with the slot 50 extending from thecircular region 48 in a lateral direction in order to accommodatediffering lateral spacing between mounting holes among differentcatheters or catheter fittings. As noted previously, however, theseslots could also extend longitudinally or in a direction skewed relativeto the longitudinal and lateral axes in order to suit a particularapplication. Also, the slot 50 in the illustrated embodiment extendsfrom the substantially circular region 48 outwardly relative to thecenter of the base 18, but the circular region 48 can be located atother positions along the corresponding slot 50 (e.g., at the outerlateral end of the slot). In addition, more than one slot can extendfrom the circular region 48.

As best seen in FIG. 8, one edge of the slot has a scalloped shape. Eachscallop has a radius of curvature generally matching a radius of acorresponding post that slides through the slot 50. The distance Dbetween the lateral end point 52 of each scallop and the opposing edgeof the slot 50 preferably is less than a diameter of the correspondingpost so as to inhibit unintentional movement of the post within the slot50, as described below.

As seen in FIGS. 5-7, the base 18 includes upstanding front and backwalls 54, 56 that are spaced from the central opening 44 in thelongitudinal direction, and extend upward from the lower wall 37 of thebase 18. An opening 58, 60 generally bifurcates each wall 54, 56,respectively, to allow the catheter to pass through one wall 54, throughthe receiving space 42 and above the lower wall 37 of the base 18, andthen out the opposite wall 56.

Sidewalls 62, 64 of the base 18 are spaced lateral from the centralopening 44 and extend upward from the lower wall of the base 18. Thesesidewalls 62, 64 are continuous with the front and back walls 54, 56 ofthe base. The corners between the sidewalls 62, 64 and the front andback walls 54, 56 preferably are rounded.

The base 18 has an open upper end that is generally defined by the upperedges of the walls 54, 56, 62, 64. Thus, while not truly parallelepiped,the retainer 16 does have a generally rectangular box-like shape withoutan upper wall and with the central openings 58, 60 formed in the frontand back walls 54, 56.

The base 18 also includes holes 66 which allow portions of the front andrear walls 54, 56 of the base 18 to flex in a longitudinal directionmore easily. This feature is advantageous to the operation of thelatching mechanism, described below.

The longitudinal, lateral and transverse dimensions of the retainer 16desirably are as small as possible, while still receiving andstabilizing the catheter 12, including its wings. In particular, thelongitudinal dimension of the base 18, which is defined between thefront and back walls 54, 56, preferably is long enough to stabilize theretained length of catheter 12. That is, the length of catheter 12 whichis secured within the retainer 16, is sufficient to inhibit rocking ofthe catheter 12 relative to the retainer 16. The longitudinal dimensionof the base 18 also is sufficient to receive the largest length ofcatheter wings for which the retainer 16 is designed.

The lateral dimension of the base 18, which is defined between thesidewalls 62, 64, similarly is sized to accommodate the largest width ofcatheter wings for which the retainer 16 is designed. It is alsopreferred that the lateral dimension be sufficient to provide aconvenient and natural grip of the base 18 of the retainer 16 whilemanipulating the covers 20, 22 and/or posts of the retainer 16. Thelateral dimension also preferably provides sufficient width to mounthinges and latch mechanisms in the present embodiment, as describedbelow.

The transverse height of the base 18 preferably corresponds to thethickest catheter wing for which the retainer 16 is designed. While thecatheter body may have a larger size than its wing thickness, the base18 accommodates this through its open central region between the covers20, 22. The base 18 thus needs not have a greater transverse height thanthat of the catheter 12, and consequently, the profile of the retainer16 is minimized.

The receiving space 42 is formed on the base 18 between the lateralwalls 62, 64 of the base 18. The receiving space 42 is desirably formedso as to accept and retain a portion of the catheter or catheterfitting, and in particular the wings thereof, without occluding thelumen of the catheter.

As seen in FIGS. 5 and 7, the covers 20, 22 have a size and shape thatdesirably is coextensive with the longitudinal dimension of the base 18.Although each cover 20, 22 preferably extends longitudinally at least asfar as the base does, the cover 20, 22 need not span the entire lateraldimension of the base. This will be discussed below. In some modes it isdesirable for the covers 20, 22 to be larger longitudinally than thebase 18. By protruding beyond the longitudinal dimension of the base 18,the covers 20, 22 can also include a flange 68 that is useful inoperation of the latch mechanism of the cover. This will be discussedbelow. In other modes, the cover need not include the flanges 68.

Each cover 20, 22 preferably is connected to the base 18 by at least onehinge 36 to provide each cover 20, 22 with at least two positions: anopen position, in which the receiving area 42 of the base 18 is exposedand into which a catheter or fitting may be inserted; and a closedposition, in which the cover 20, 22 is located over the base 18 andcovers at least a portion of the receiving area 42. In the closedposition, the covers 20, 22 are held in place by a latch mechanism,described below, to inhibit the unintentional transverse release of thecatheter or catheter fitting from the receiving area 42 of the base 18.The covers desirably are sufficiently sized to accommodate the necessarylatch mechanism components and to extend over or around at least aportion of the posts 70 (and possibly receive upper ends of the posts)when in the closed position. As explained in greater detail below, theinteraction between the upper portions of the posts 70 and the covers20, 22 inhibits movement or play of the post upper ends relative to thecovers 20, 22. Consequently, this interaction inhibits the posts 70 fromdeflecting or bending, at least in the longitudinal direction, when thecatheter is tugged to maintain a secure connection between the posts 70and the catheter 12.

In the embodiment shown in FIGS. 5-7, each cover 20, 22 of the coverassembly 19 has a hinge 36 and a latch mechanism, such that each covercan be independently placed into an open or a closed position. In thisembodiment, the covers 20, 22 do not contact one another when both arein the closed position, as shown in FIGS. 2 and 4. Although both coversextend from the lateral sides 62, 64 of the base 18 toward the center ofthe retainer 16, by reducing the lateral dimension of the covers 20, 22such that the components do not interact when closed, it becomespossible to effectively secure catheters or fittings that extendtransversely beyond the height which could be contained below the coversif the covers were to meet. By allowing such “centrally bulky” cathetersor fittings to be accepted, the anchoring system 10 is more universaland has a lower profile as noted above. An example of how the retainer16 and posts hold a catheter 12 is shown in FIG. 4.

On each cover 20, 22, a recess 72 is formed which will lie over the postopening 46 on the corresponding half of the base 18 when the cover is inthe closed position. This recess 72 preferably extends from a pointdirectly above the substantially circular region 48 of the post opening42 and along the length of the elongated slot 50 of the correspondingpost opening. The recess 72 desirably is deep enough and wide enoughalong its length to freely receive the upper end of the correspondingpost 70, which protrudes through the corresponding post opening 46, suchthat the post 70 does not interfere with the movement of the cover 20,22 into the closed position. The recess 72 also receives the upper endof the post 70 when the cover 20, 22 is closed to inhibit the post 70from bending in the longitudinal direction. Of course, in someapplications, the post 70 can extend through the cover 20, 22 withoutinterfering with movement of the cover and with the cover capturing aportion of the post to inhibit bending of the post in the longitudinaldirection.

As can be seen in FIG. 7, the covers 20, 22 are coupled to the base 18by flexible couplings or hinges 36. Each hinge 36 preferably comprises aflexible band that can take any number of forms to mechanically connectthe cover 20, 22 to the base 18 while permitting pivotal movement of thecover 20, 22 relative to the base 18 so as to enable engagement ordisengagement of these parts, as described below.

In the illustrated embodiment, the band is formed of flexible material,desirably of the same material from which the base 18 and cover 20, 22are comprised. Advantageously, the hinges 36 are integrally molded withthe base 18 and the covers 20, 22 to form a unitary member, as notedabove. The hinges 36 are located at an outer edge of the base 18 and thecover assembly 19; however, the hinges 36 need not be laterally locatedat an extreme end of the base 18 or cover assembly 19. The illustratedembodiment shows the hinges 36 positioned near the same plane as theupper edges of the base 18 for ease of manufacture.

As best understood from FIG. 5, the width of the hinges 36, as measuredin the longitudinal direction, is desirably less than that of either thebase 18 or the covers 20, 22 to allow some leeway or play when engagingor disengaging the cover 20, 22 to the base 18. That is, this shapeallows the hinge 36 to twist to some degree to compensate for somemanufacturing tolerances; however, the hinges can have at least as largeof a longitudinal dimension as the base 18 and/or the covers 20, 22.

The hinges 36 are desirably integrally formed along common correspondingexterior surfaces of the covers 20, 22 and base 18. Each hinge 36 has agenerally U-shape 74 when the cover is closed, and extends from both thebase 18 and the cover 20, 22 in the lateral direction to the side of theretainer 16. A gap, corresponding to a transverse height of the hinge36, exists between the base 18 and covers 20, 22. This gap, however, canbe reduced or eliminated from the retainer for some applications byusing a different hinge design.

The hinges 36 enable each cover 20, 22 to move between the open positionand the closed position. The open position, shown by cover 22 in FIGS. 5and 7, is characterized by exposing the corresponding post in thetransverse direction. When both covers are in the open position, asshown in FIG. 3, the retainer 16 is capable of receiving a portion ofthe catheter 12. The closed position, shown FIGS. 4, 5 and 7, ischaracterized by the cover 20 lying in contact or in near contact withthe base 18 so as to position the post within the recess 72 in the cover20. When both covers 20, 22 are in the closed position, as shown in FIG.4, the retainer 16 surrounds the received portion of the catheter 12.

The hinges 36 need not provide 180° of movement for the covers 20, 22relative to the base 18 to establish a closed position and a fully openposition. For instance, the hinges 36 can permit a smaller degree ofmovement (e.g., 90°) between the base 18 and the covers 20, 22 whilestill providing enough space to transversely insert the catheter 12 intothe retainer 16 when both covers 20, 22 are open.

To hold the covers 20, 22 to the base 18 and to effectively retain thecatheter 12 or catheter fitting within the retainer 16, the base andcover include structures that interengage when the covers are in theclosed position. As can be seen in FIG. 6, a latch mechanism 80 isprovided for securing the covers 20, 22 in the closed position relativeto the base 18. The latch mechanism 80 comprises at least one movablekeeper 82 and at least one latch 84. In the illustrated embodiment ofFIG. 6, the keeper 82 is disposed on the cover 20 while the latch 84 isdisposed on the base 18. However, those skilled in the art willrecognize that the keeper can be disposed on the base and the latch canbe disposed on the cover.

Each keeper 82 extends from the cover 20 toward the base 18 of theretainer 16 from the lower side of the cover 20 (“lower” as seen whenthe cover is in the closed position as in FIG. 6). In addition toextending from the cover 20, each keeper 82 has at the end farthest fromthe cover a tang 86 that extends in the direction toward thecorresponding latch 84. This tang 86 is rounded as seen in FIG. 6;however, the tang can have a surface that lies generally normal (e.g.,±15° from perpendicular) to the transverse axis.

The latch 84 comprises a protrusion 88 that is formed on the base 18 ata location that will interact with the tang 86 of the keeper 82 when thecover 20 is in the closed position. This can be seen in FIG. 6. In theillustrated embodiment, a protrusion 88 is formed on the front and backwalls 54, 56 of the base 18. The latch 84 is located along the wall 54,56 of the base at a position adjacent to a hole 66 in the base 18. Bypositioning the latch 84 at such a location, it is more able to flex inthe longitudinal direction. This is because the hole 66 reduces theresistance of the base 18 in that region to deformation.

As the cover 20 is moved into the closed position, the keeper 82 willflex as the tang 86 moves past the protrusion 88 of the latch 84, andthen will relax or spring back into its original state once the tang 86has moved past the protrusion 88. This will prevent the cover 20 fromunintentionally moving out of the closed position. The lower side of theprotrusion 88 preferably has a complimentary shape to that of the top ofthe tang 86 to promote engagement between them when the cover is closed.In the illustrated embodiment, the protrusion 88 is preferably roundedin the same manner as the tang 86 of the keeper 82. In anothervariation, the protrusion has a generally flat lower surface that isupwardly included at about 10° relative to the plane of the bottom wall37 and the upper surface of the tang 86 has a similar complimentarysurface that slopes downward by 10°.

In order to allow disengagement of the latching mechanism 80, it isnecessary for the keeper 82 to flex as the tang 68 moves past theprotrusion 88 of the latch 84. In one mode of operation, this can beaccomplished by pressing upon a flange 68 or other extension of thecover 20. By pressing upon the flange 68, the cover 20 bends, moving thetang 86 of the keeper 82 away from the protrusion 88 of the latch 84,and allowing the cover 20 to be moved out of the closed position withoutexerting excessive force upon the cover. Desirably, such a flange 68 isformed integrally with the cover 20 of the retainer 16. The reducedthickness of the cover 20 along its center section, which is created bythe recess 72, aids in the cover bending in this manner,

As best seen in FIG. 7, each cover 20, 22 also includes an overhang 90formed on its inner edge (i.e., the edge closest to the central opening44). This overhang 90 preferably is sized to allow the fingertip orfingernail of the healthcare worker to slip underneath the overhang topull up the cover 20, 22 in another mode of opening the cover. Theupward force applied causes the tang 86 to slide over the protrusion 88to disengage the latching mechanism 80. As a result, the overhang 90provides another way to open the cover 20, 22.

In the illustrated embodiment, each cover 20, 22 has two keepers 82,requiring two latches 84 on the base. The latch mechanisms 80 on eachcover are formed as mirror images of each other.

In order to aid the manufacture and assembly of the retainer, the postsmay be formed as part of a post platform 92. An embodiment of the postplatform 92, which includes a plurality of movable posts 70, isillustrated in FIGS. 9, 10 and 11. The post platform 92 includes anattachment button 94 for connecting the platform 92 to the base 18,posts 70 that are configured to extend through the post openings 46 inthe base 18, and connectors 96 which at least initially hold the posts70 to the attachment button 94. In the illustrated embodiment, theplatform 92 is attached to the base 18 from below by aligning theattachment button 94 with the central opening 44 in the base 18,inserting the posts 70 through the post openings 46, and pressing theplatform 92 upward into the recess 40 on the lower side of the base 18.When fully inserted, the larger radius on the upper portion of theattachment button 94 will snap into position in the central circularopening 44. In one variation, the upper portion of the attachment button94 can be disposed within a countersink formed on the upper side of thebottom wall 37. The pair of posts 70 then protrudes through the postopenings 46 of the base, and may move laterally within the lateralextent of their respective post openings 46 in the base 18.

While the present embodiment shows posts 70 that are connected to theattachment button 94 and to each other, this arrangement is notnecessary for advantageous operation of the retainer. Those of ordinaryskill in the art will appreciate that the connected arrangement of theposts 70 on the platform 92 is largely to facilitate manufacture andconstruction of the retainer.

The attachment button 94 comprises a cylindrical peg of a diameter toallow it to be inserted through the central circular opening 44 of thebase 18 from the lower, or proximal, side. A distal portion of thecylindrical peg has a larger radius than the proximal portion of theattachment button. This upper portion is also of slightly larger radiusthan the central circular opening 44 in the base 18. The upper edge ofthe attachment button 94 is preferably chamfered to allow the button tobe easily inserted through the central circular opening 44 of the base.Once inserted into the central circular opening, the larger radius atthe distal portion of the button 94 will prevent the button from beingpulled out of the base 18 in the proximal direction.

The connectors 96, illustrated in FIG. 11, comprise extensions from thelowest portion of the attachment button 94 which extend laterallytherefrom and connect to the lowest portion of the posts 70. Desirably,these connectors 96 allow the distance at which the posts 70 aredisposed from the attachment button 94 to vary after the retainer isassembled.

One way to accomplish this is illustrated in the embodiment of FIGS. 9,10 and 11. Each connector 96 comprises a leash that extends parallel tothe base 18 of the retainer away from the attachment button 94 at anangle to the lateral direction. The leash can be straight when fullyextended or can follow a semi-looped or curved path. This path can alsoassume a zigzag or similar shape. The shape of the leash allows thelateral extension of the leash to be adjusted by permitting the leash toflex. In the illustrated embodiment, each connector 96 can have enoughflexibility to allow it to remain intact while spanning distancesranging from the farthest lateral position in the post opening 46, tothe minimum lateral distance defined by the circular portion 48 of thepost opening. In the illustrated embodiment, this is accomplished byallowing the leash to bend and fold back upon itself. In a variation,the leashes can be configured to bias the posts 70 inward or outward. Inanother variation, however, once the posts 70 are assembled in the base,the posts do not need to be tethered together, and the leashes can bedesigned to break after assembly.

One of the posts 70 is disposed at the lateral end of each connector 96.The posts 70 comprise substantially cylindrical members that extendtransversely in the distal direction from a lowest portion that isattached to the corresponding connector 96 of the post platform 92. Theposts 70 desirably also include a flange 98, located distally along thelength of the cylinder such that it will lie above the bottom wall 37 ofthe base 18 when the platform 92 is inserted into the retainer base 18.This flange 98 is preferably sized to have a radius larger than theradius of the elongated slot 50 portion of the post opening 46, butsmaller than the circular section 48 of the post opening 46. In thismanner, the flange 98 can be inserted through the circular section 48 ofthe post opening 46 along with the post 70, and then remain above thebase 18 of the retainer when the post 70 is moved to a position alongthe length of the elongated slot 50. The flange 98 stabilizes the post70 and maintains its proper orientation with regard to the base 18,i.e., the flange 98 maintains the post 70 in a transversely uprightposition and inhibits significant rocking of the post.

It is also possible to make use posts which do not possess a flange. Anexample of such a post platform is shown in FIGS. 11A-11C. This postplatform is used in substantially the same manner as the platform 92shown in FIGS. 9-11, but does not make use of flanges to stabilize theposts. Such flange-less posts are suitable for use with bases in whichthe post openings 46 do not include circular regions 48, but onlyconsist of an elongated slot 50. An example of such a base is shown anddiscussed below.

The circular region 48 of the post opening 46 is located at theinnermost lateral position that a post 70 would be desirably located,and the track 50 extends to the outermost lateral position that a post70 would be desirably located. By moving the post laterally, it can bepositioned as desired at any location along the length of the slot 50.Along the length of the slot 50 are positioned the series of protrusionsor scallop end points 52 which extend into the slot 50 and effectivelynarrow the width of the slot at the position of each protrusion 52, asnoted above. At the locations of the protrusions 52, the width of theslot 50 is comparable to, or slightly narrower than, the width of theposts 70 which will extend through the post opening 46. This arrangementprovides a ratcheting action for positioning the post 70 at the desiredlocation, and then retaining the post at said location.

Because the material of the base 18 and post 70 are slightly elastic, itis possible to push the post along the slot 50 past a protrusion 52 intothe section of the slot that is wider between the protrusions, even ifthe width of the slot at the protrusion is slightly narrower than thediameter of the post 70. However, once in the desired position along thelength of the slot 50, the protrusions 52 will inhibit unintendedlateral motion of the post 70 from its location. This ratchetingarrangement allows effective positioning of the posts 70 to any desiredlateral position between protrusions 52 without undesirable inadvertentmotion of the posts once positioned.

Although the number of posts 70 shown in the instant embodiment is two,any number of posts may be used to accommodate a specific purpose. Forexample, if a particular catheter fitting contained four holes, aretainer designed to retain that fitting would desirably have four postsextending through four post openings in the base of the retainer.Similarly, if a “Y” shaped catheter or fitting was to be retained, threeposts could be used to provide the desired stability.

The post 70 and/or the post platform 92 can be formed from a variety ofmaterials using various known manufacturing methods. For example, thepost 70 and/or post platform 92 can be injected molded. Suitablematerials for such include without limitation: plastics, polymers, orcomposites such as polypropylene, polyethylene, polycarbonate,polyvinylchloride, acrylonitrile butadiene styrene, styrene butadiene,nylon, olefin, acrylic, polyester, moldable silicon, thermoplasticurethane, thermoplastic elastomers, thermoset plastics and the like. Theposts and post platform 92 are preferably formed by injection moldingusing a nylon, such as Zytel 101 L, available commercially from E.I. duPont Company of Wilmington, Del. However, other materials can be used,and the post platform can comprise a multi-piece assembly.

After the post platform 92 has been attached to the retainer base 18,the retainer 16 then is attached to the upper surface 24 of the anchorpad 14. The base 18 desirably is secured to the upper surface 24 by asolvent bond adhesive, cyanoacrylate or other bonding material. One suchadhesive is available commercially as Part No. 4693 from the MinnesotaMining and Manufacturing Company (3M). With certain types of polymer(e.g., a styrene butadiene polymer), a UV cured adhesive also can beused, as known in the art. It is important when attaching the base 18 tothe anchor pad 14 that the post platform 92 is not secured to the anchorpad as well. The posts 70 in this mode must be free to slide within therecess 40 on the underside of the base 18 and within the post openings46 for the posts 70 to be properly movable between different desiredlocations.

The anchoring system 10 can optionally include a fitting for mountingthe catheter to the retainer 16. If used, the fitting can take the formof a conventional box clamp and a soft wing clamp. Box clamps and softwing clamps are commercially available from Arrow® for use with its CVC.Other clamps with suture wing extensions are currently in commercial usewith Quinton® Hemodialysis catheters, Cook® PICC's, Baxter® CVCs and B.Braun® CVCs. Those skilled in the art will find application for thepresent invention with any of these or other clamp configurations. Aswill be clear from a discussion below, the fitting can also be replacedwith an inter-line connector or adaptor, such as those used to connectthe catheter to a supply, delivery or drainage line.

When the anchoring system 10 is assembled as described above, thereceiving space 42 formed between the base 18 and covers 20, 22 whenthey are in the closed position defines a channel. The channel iscapable of receiving a portion or length of the catheter and isgenerally configured to house, grip and secure the affected catheterportion. In the illustrated embodiment, the channel has a generallysymmetrical shape. However, other cross-sectional shapes may be used forparticular applications, such as for supporting a Y-site catheter.

Although the shape of the channel may vary depending upon itsapplication (i.e., depending upon a shape of the retained portion of themedical article for which the retainer is designed to be used), thelength of the channel, as mentioned above, is desirably sufficient inthe longitudinal direction to stabilize the catheter, rather than actingas a fulcrum for the catheter, as was discussed above. That is, theretainer 16 receives a sufficient length of the catheter to inhibitmovement of the catheter in the lateral, longitudinal and transversedirection (i.e., to inhibit yaw, pitch and axial movement of thecatheter), without kinking the catheter.

The internal width of the channel can be varied by adjusting theposition of the posts 70. By moving or sliding the posts along theirslots 50, the distance between the posts can be varied. This isespecially important when the anchoring system 10 is used with a widevariety of catheters and catheter fittings that may not have similarjuncture configurations or suture hole spacing.

With the covers 20, 22 in the closed position, a section of the catheter12 is captured within the retainer 16. Thus, the retainer at leastrestricts, if not prevents, transverse and lateral movement of theretained section of the catheter. Transverse movement is also restrictedwhen the covers 20, 22 are open by the height of the posts 70, whichinhibit upward migration of the catheter 12 and/or catheter fitting.Inhibiting movement of the catheter in the longitudinal direction whenthe catheter 12 is secured within the retainer 16 is desirablyaccomplished by the posts 70 and holes.

Operation

In operation, as best seen in FIGS. 3, 4, and 12, the covers 20, 22 aremoved toward the closed position. The relatively thin strip of materialforming the hinge 36 allows the hinge to bend when finger pressure isexerted on the covers to close them. The tangs 86 at the end of thekeepers 82 contact the protrusions 88 of the latches 84 on the base 18when the covers 20, 22 near their closed position. Continued pressureforces the keepers 82 inward (toward each other) to permit the tangs 86to pass beyond the protrusions 88. The tangs 86 snap over theprotrusions 88 under the spring force provided by the deflected keepers82 when the covers 20, 22 sit atop the base 18. The interaction betweenthe tangs 86 and the corresponding surfaces of the latches 84 hold thecovers in this position.

To open the latch mechanism 80, a healthcare worker presses inwardly onthe protruding flanges 68 of the covers 20, 22 or lifts up the covers20, 22, as described above. The resulting inwardly directed forcedeflects the keepers 82 and moves the tangs 86 inward to clear theprotrusions 88 of the latches 84. The healthcare worker can then openthe covers and expose the posts 70 and the base 18.

This releasable engagement between the covers 20, 22 and the base 18allows the same retainer 16 to be used for an extended period of time,while permitting repeated attachment and reattachment of the catheter 12or fitting to the anchoring system 10. In addition, the hinges 36 whichconnect the covers 20, 22 to the base 18 ensure that the covers will notbe lost or misplaced when the catheter 12 is detached from the anchoringsystem 10. The healthcare worker wastes no time in searching for amisplaced cover, or in orienting a cover prior to latching, and he orshe is not required to carry a separate instrument to detach thecatheter from the anchoring system.

A healthcare worker may secure a catheter (or other medical article) toa patient using the above-described anchoring system (or a readilyapparent modification thereof). The healthcare worker first opens theretainer 16 to expose the posts 70. Once opened, a catheter 12 may betransversely aligned over the posts 70, as shown in FIG. 3 and FIG. 12.The catheter 12 may then be placed into the channel formed between theposts 70. Optionally, openings formed on either the catheter 12 or afitting can then be slid over the posts to further secure the catheterto the retainer 16. Once the catheter is so secured by the posts, thecovers 20, 22 are closed and latched in the manner described above, asseen in FIG. 4.

If the catheter 12 is pulled in the longitudinal direction, the holdingeffect of the posts 70 and holes prevent the catheter from pullingthrough the retainer 16. The retainer thus inhibits longitudinalmovement of the catheter relative to the retainer. Interaction betweenthe base 18, covers 20, 22, posts 70 and holes restrict movement of thecatheter 12 in the transverse and lateral directions. The interactionbetween the posts 70 and the covers 20, 22 also inhibits significantbending of the post upper ends in the longitudinal direction which, ifallowed, would permit the catheter to slide off the posts.

Importantly, the base 18 and covers 20, 22 do not crimp or kink thecatheter body when it is inserted within the channel and about the posts70. Moreover, although the posts do bear against the catheter body,their limited pressure does not significantly occlude the correspondingcatheter lumen(s).

Fixed Position Post Platform

A variation to that described above is produced using the same anchorpad 14, base 18 and covers 20, 22, but substituting a different postplatform 100 for that described above. Specifically, the post platformof this alternate embodiment does not provide for movable posts; theposts are in fixed positions on the platform, and therefore, the usercannot adjust the spacing of the posts.

An example of a post platform 100 consistent with the present embodimentcan be seen in FIGS. 13 to 16. The platform 100 still consists ofconnectors 102, an attachment button 104, and posts 106. However,instead of the connectors being flexible leashes that allow the distancebetween the post 106 and the attachment button 104 to be adjusted, theconnector 102 comprises a lateral extension of the lowest portion of theattachment button 104 that also acts as the lowest portion of each post106. Because there is no need for flexibility, the geometry of theconnector is simplified. This fixed post arrangement also provides forgreater stability for the posts 106 than the movable position postplatform 92 does. It is most significant to note that in such anembodiment there is no need for the flange 98 described with referenceto FIGS. 9 and 10 above. Not only is this flange not needed to providelongitudinal and lateral stability to the post 106 as it extends throughthe base 18, but the presence of such a flange would actually preventthe insertion of the post platform 100 into the base 18 in any casewhere the posts 106 were not positioned directly beneath the circularregion 48 of the post opening 46. By eliminating the flange 98, thefixed position post platform 100 may be manufactured with any spacingdesired between the posts 106, as long as the position of the postsfalls somewhere along the length of the post opening 46 in the base 18of the retainer 16.

The greater stiffness and stability provided by producing a fixedposition post platform 100 allows the retainer 16 to be more easilyassembled. While it also eliminates the possibility of adjusting theposition of the posts 106 to accommodate different sized catheters orcatheter fittings, it allows a simpler design to be used when thelocations of the posts are known in advance to be at a fixed position.

Additionally, the use of a fixed position post platform 100 simplifiesthe process of adhesively attaching the base 18 to the anchor pad 14because there is no need to avoid attaching the underside of the postplatform 100 to the anchor pad 14. Compare FIGS. 17 and 18. In themovable post arrangement, shown in FIG. 17, the post platform 92, andparticularly the connectors 96, must be free to flex and extend in orderfor the posts 70 to move. However, in the fixed position post platform100 (shown in FIG. 18), no motion is possible. Therefore it isacceptable and even desirable for the post platform 100 to be bonded tothe anchor pad 14 in the same manner as the base 18 of the retainer isattached to the anchor pad 14.

The fixed position post platform 100 can be formed of any of thematerials noted above in connection with the movable post platform 92.The fixed position post platform 100 in a preferred embodiment isinjected molded of a Lexan polycarbonate available commercially fromGeneral Electric Company, as Part No. 144R.

Single Movable Post Retainer System

An additional preferred embodiment of the present invention can be seenin FIGS. 19 and 20. The anchoring system 210 illustrated includes aretainer 220 and an anchor pad 294. The retainer 220 is sized andconfigured with one, and preferably two or more posts 230, 250 to acceptand retain a section of a catheter 212 (FIG. 28) within the anchoringsystem 210, either directly or by way of a fitting 214. The retainer 220comprises a base 222 and a cover 224. The cover 224 is detachablysecured to the base 222 and movable between open and closed positions.The anchor pad 294 secures the retainer 220 to a patient's skin. Theanchor pad 294 is substantially similar to the anchor pad describedabove for use in the previous embodiment of the invention.

Unlike the embodiments described above, this embodiment of the presentinvention does not make use of a post platform that comprises multipleposts. Rather, in the present embodiment, one post is integrally formedwith the base of the retainer, and the other is inserted laterally intoa track that runs along the bottom of the base. Because the samecharacteristics of flexibility and strength and ease of formation arepresent in this embodiment, the same materials are most preferable toconstruct the instant embodiment as were preferable to construct theprior embodiments.

Although the embodiment discussed below is described using particularranges of sizes for various components, the sizes given are merelyexemplary. Those skilled in the art will recognize that the componentsof any embodiment of the present invention described herein may be sizedhowever is appropriate to the catheter or other device to be secured, oras is otherwise necessary according to the circumstances under which thedevice is used.

The illustrated embodiment shows the base 222 including first and secondsides 226, 228. The first side 226 lies generally between one set oflateral ends of the base 222, and the second side 228 lies at anopposite set of lateral ends of the base 222.

FIG. 21 shows a fixed post 230 that is integrally formed with andextends upwardly from the first side 226 of the base 222. The base 222desirably includes a pair of posts (the second, movable post 250 isdetailed below). The base 222, however, can include additional posts tosuit a specific application. For example, where the retainer 220 isdesigned to secure a relatively large fitting, the base 222 can includefour posts arranged at the corners of a rectangle, for greaterstability. Similarly, three posts can be used to firmly anchor a Y-sitefitting.

As shown in FIG. 22, the fixed post 230 includes a shank or shaft 232,attached to and extending upwardly from the base 222. The post 230 canhave a variety of lengths, depending upon the particular application andthe particular fitting to which they interact to mount the catheter 212.For anchoring catheters and medical tubing, the fixed post 230 desirablyhas a length of about 20 mm or less, and more particularly a length ofabout 7 mm; however, longer or shorter lengths are also possible. Theshaft 232 of the fixed post 230 has a diameter sufficient to perform itsstructural function, as described in more detail below, and depends onthe material chosen for the base and post. The illustrated post 230comprises a slightly elastic material, with a diameter between 0.5 mmand 3.0 mm and particularly about 1.5 mm. However, the illustratedembodiment shows the shaft 232 configured substantially as a cylinder tobest match circular holes which are most commonly used on wingedcatheters or catheter fittings. However, the shaft can be configuredwith a host of other geometries, such as square, triangular, oval,polygon or the like, to match the hole configuration of various othercatheters or catheter fittings.

FIG. 23 shows a track 242 formed in the base 222. The track 242 isarranged substantially linearly along the lateral axis and extendsproximal the fixed post 230 to the second side 228 of the base 222. Thetrack 242 has sufficient width to accommodate a movable element therein.The edges of the track 242 are of relatively smooth and solidconstruction such that the movable element can move or slide within thetrack 242 in a fluid manner without snagging on portions of the track242.

The track 242 has a substantially inverse T-shaped configuration, as canbe seen in FIG. 24, with a first channel 246 and a second channel 248.The width of the second channel 248 is larger than the width of thefirst channel 246. A portion of the first channel 246 is desirablycoplanar with the surface of the base 224 and extends toward the anchorpad 294. The first channel 246 desirably has a lateral width of 0.5 mmto 3.0 mm and particularly about 1.65 mm. The first channel 246desirably has a transverse height of 0.1 mm to 0.8 mm and particularlyabout 0.64 mm and communicates with the second channel 248. The secondchannel 248 further extends toward the anchor pad 294. The width of thesecond channel 248 is desirably between about 0.5 mm and 8.0 mm andparticularly about 3.0 mm. The second channel 248 desirably has atransverse height of 0.05 mm to 1.0 mm and particularly about 0.64 mm.

The T-shaped configuration of the track 242, achieved by therelationship between the first and second channels 246, 248, inhibitsrocking of the movable element and retains it within the channels(detailed below). This configuration also provides for easy andinexpensive manufacture because a T-shaped track mold, desirablyextruded by a T-shaped element, has an inherently stronger constructionthan other non I-beam structures, such as a dovetail shape. The trackmold is thus less susceptible to damage from heat and pressure forceswhich occur during the molding process. In contrast, if a dovetail shapeis used, the thinned edges become susceptible to melting and otherdeformations. Although a T-shaped track configuration is preferred,other track configurations, such as a dovetail shape, may be used withthe anchoring system.

FIG. 25 shows a movable post 250 including a shaft 232 sized andconfigured similar to the fixed post 230 and positioned along the base222. The shaft 232 of the movable post 250 is sized and configured to bereceived into the first channel 246 of the track 242. The diameter ofthe shaft 232 is desirably similar to the lateral width of the firstchannel 246, but can have diameter that is appreciable greater or lessthan the lateral width of the first channel 246 depending on theparticular application of the anchoring system and the materials used toform the various elements of the anchoring system. Desirably, thediameter of the shaft 232 may be made anywhere from about the same widthto 1 mm less than the lateral width of the first channel 246, andparticularly about 0.13 mm less. This close-fit configuration providesfrictional forces between portions of the shaft 232 and first channel242 and allows the post 250 to reluctantly slide within the firstchannel 246 of the track 242 while remaining substantially upstandingabout the transverse axis.

The movable post 250 desirably further includes a platform 252 fromwhich the post 250 extends. The platform 252 extends along a planedefined by the longitudinal and lateral axes and is sized and configuredto be received into the second channel 248 of the track 242. Desirably,the relationship between the lateral width of the platform 252 and thelateral width of second channel 248 is similar to that of the movablepost 250 and first channel 242 in order to similarly provide a close-fitconfiguration between the platform 252 and second channel 248. Thus, theplatform 252 can reluctantly slide within the second channel 248 of thetrack 242 while remaining substantially upstanding about the transverseaxis. Although the movable post shown in FIG. 25 has a platform whoselength and width are different so as to form an elongated roundedrectangle, those of skill in the art will recognize that the platformmay take on other shapes, such as square, oval, or circular withoutaltering the operation of the post within the track.

By this post-platform design, the post 250 and platform 252 provides asubstantially T-shaped structure that can be accommodated by theT-shaped track 242. Alternatively, if an alternative track configurationis used, such as dovetail shape, the post-platform design is modified tosimilarly provide a close-fit relationship with the track, as will beunderstood by one skilled in the art.

As detailed above, the substantially upstanding post 250 and platform252, which are respectively closely fit into the smooth first and secondchannels 246, 248 of the track 242 cooperate to provide a movablestructure which can reluctantly slide along the track 242 but which canremain upright, resist axial rocking, and prevent escape from the track242 when axial or rotational forces are applied to the post 250. Thereluctant sliding is such that a force applied by the finger(s) of ahealthcare worker can slide the post 250 and platform 252 along thetrack 242. Any unintentional movement of the post 250 and platform 252,without such applied force, is resisted. The post 250 and platform 252can also be reproducibly introduced into, and recalled from, the track242 (FIG. 21). That is, the post and platform can enter the track 242along the terminal portion of the track 242, which is co-extensive withthe second side 228 of the base 222, and can similarly exit the track242 from this terminal portion.

The platform 252 is desirably permanently affixed to the post 250 andformed unitarily therewith. However, the post 250 and platform 252 maybe separately formed and then connected using any of a variety ofsuitable attachment means known to those skilled in the art. Forexample, the post can have a threaded portion that screws into athreaded portion of the platform, or the post can have a notch that issnapped into a recess in the platform. Chamfers can also be used toguide and position the post with respect to a seating area on theplatform.

As best seen in FIGS. 22 and 23, the cover 224 has an elongate shapewhich desirably is coextensive with the planar size and shape of thebase 222 (i.e., the cover desirably has the same geometric shape andsize as the base 222); however, the cover 224 need not be the same sizeor shape as the base 222. For instance, the cover 224 can be sized toextend beyond any of the lateral, transverse, or longitudinal edges ofthe base 222 or, alternatively, can be sized so as to not extend to thelateral, transverse, or longitudinal edges of the base 222. The covercan also include a skirt or flange (not shown) that extends over and/orabout the base 222 or any portion thereof.

The cover 224 desirably has a sufficient size to cover the posts 230,250 in the base 222 and to accommodate a portion of the latch mechanism270 and hinge 264 which operate between the base 222 and the cover 224as described below. The cover 224 also desirably is of a dimension thatprovides for easy manipulation. For example, the cover's size easilyaccommodates the grasp of a healthcare worker, and allows formanipulation of the device while wearing surgical gloves.

The cover 224 includes a first side 254 which lies generally between oneset of lateral ends of the cover 224. The first side 254 of the covertherefore generally corresponds to the first side 226 of the base 222.The cover 224 also has a second side 256. The second side 256 liesgenerally between one set of lateral ends of the cover 224, opposite ofthe first end, and therefore corresponds generally to the second side228 of the base 222.

Still referring to FIGS. 22 and 23, a dome 257 is formed between thefirst side 254 and the second side 256 of the cover 224. The dome 257provides a transversely extended area that can accommodate the centralportion of larger, bulkier catheters and catheter fittings. Because manycatheters and catheter fittings are manufactured “centrally bulky,” thedome 257 allows these catheters or catheter fittings to be accepted intothe retainer 220 when in the closed position and assists in theuniversal aspect of the present invention.

A recess 258 is formed as an elongated body on the cover 224 and runsgenerally parallel to the track 242 when the cover is in the closedposition. The recess 258 is arranged to receive the distal ends of theposts 230, 250 when the cover 224 is in the closed position. The recess258 allows the posts 230, 250 to avoid contact with or otherwise notimpede the cover 224 when the cover 224 is moved to the closed position(the top of the posts 230, 250 may be at a transversely higher elevationthan the bottom of the cover 224) and also inhibits motion of the postsin the longitudinal direction. The dome 257 may also serve as apartition to separate the recess 258 into first and second areas, eacharea being sized to acconmodate a post.

The recess 258 desirably has a width slightly larger than the width ofthe first channel 246. This larger width compensates for inclination and“play” in the generally upstanding movable post 250, which may be angledanywhere between slightly greater or less than normal to the base 222(generally 75 to 115 degrees). This play generally results from theclose-fit configuration of the post 250 and platform 252, which aredesirably configured dimensionally smaller than their correspondingtracks 246, 248. The transverse height of the recess 258 is desirablybetween about 1.0 mm and 2 mm and particularly about 1.27 mm. The recess258 may have one or more chamfered edges (not shown) to transverselyguide the post 230 into the recess 258.

Although the recess 258 desirably forms an elongated body runninggenerally parallel to the track 242 when the cover is in the closedposition, a wide variety of other configurations may be used. Forexample, the first and second areas of the recess 258 can be modified sothat the second area has a longer longitudinal length than the firstarea. So configured, the second area length can generally correspond tothe track 242 length, while the first area length can generallycorrespond to the fixed post 230 diameter (FIG. 26). For anotherexample, the recess may extend to the terminal ends of the first andsecond sides 254, 256 of the cover 224 for ease of manufacture. The onlyrequirement of the recess 258 is the capability to receive the posts230, 250 and allow the cover 224 to move to the fully closed position.

The flexible couplings that may be used to connect the cover 224 to thebase 222 are substantially as described in the previous embodiments. Thedifference being that in the present embodiment the cover 224 comprisesonly a single piece and hence only a single hinge 264 is needed.

The means of operation is significantly the same for this anchoringsystem as for the previous system as well. The potential advantages aresimplification of the manufacture and design.

The latching mechanism 270, while operating in a similar manner to thepreviously described embodiments, is slightly differently constructed inthe present embodiment. As best seen in FIG. 30, each keeper 272 extendstoward the base 222 from the second side 256 of the cover 224. A tang276 is formed at a lower end 278 of the keeper 272. Desirably, the lowerend 278 of the keeper 272 is relatively blunt and smooth to prevent itfrom puncturing the gloves or skin of a healthcare worker or catching onother materials. An operator lever 280 extends to the side of the keeper272 and includes an enlarged platform or ear 282 at its outer end suchthat a component of a lateral force applied to the lever 280 will causethe keeper 272 to deflect inward. The entire keeper 272 desirably isformed with the cover 224 to form a unitary piece.

The latch mechanism 270 also includes a receptacle 284 that receives thetang 276 and at least a portion of the keeper 272. The latch receptacle284 includes an inner notch 286 into which the tang 276 snaps into whenthe cover 224 is in the closed position; however, the tang 276 can bearranged in the receptacle 284 and the notch 286 be positioned on thekeeper 272 to accomplish the same effect. The latch 274 desirably isformed with the base 222 as a unitary piece.

In the illustrated embodiment, the cover 224 includes two keepers 272that are mirror images of each other. And, the latch 274 includes twonotches 286, each of which is arranged to receive one of the keepertangs 276 when the cover 224 is closed.

An entrance of the receptacle 284 includes chamfered edges 288. Thechamfered edges 288 slope inward toward the center of the receptacle 284to cause the keeper 272 to bend inward when inserted into the latchreceptacle 284.

Lower Support Member

In some cases it may be advantageous to provide a lower support memberwhich lies between the upper surface of the anchor pad and the bottom ofthe retainer base. The lower support member thereby provides a smoothsurface for the bottom of the groove of the base, rather than having thebottom surface of the groove formed by the upper surface of the anchorpad. Additionally, because the lower support member now forms the bottomsurface of the retainer, it is practical to adhere the entire bottomsurface of the retainer to the anchor pad, even in embodiments makinguse of movable posts.

The lower support member 300 as shown in FIGS. 32-34, comprises agenerally flat plate 305 of generally the same planform shape as thelower portion of the retainer base 318. The lower support member 300 maypreferably be manufactured from the same materials and using the sametechniques as are suitable for the manufacture of the retainer base 318.In some preferred embodiments, the lower support member 300 and base 318may be manufactured as a unitary piece, and then separated prior toassembly into the final retainer, as will be discussed below. Such aunitary lower support member 300 and base 318 are shown in FIGS. 32-34.

As can be seen in FIGS. 32-34, the lower support member 300 comprises aflat plate 305 and a set of tabs 320 which extend therefrom. In theillustrated embodiment, the tabs 320 extend in a direction opposite thedirection in which the walls of the base 318 extend from the bottom ofthe base. However, the tabs 320 need not extend in this direction if thelower support member 300 is to be separated from the base 318 prior toassembly. Each tab 320 is preferably slightly flexible and contains achamfered tang towards its tip. For manufacturing purposes it may bedesirable to place a hole 350 on the plate 305 adjacent to each tab 320.

As also shown in FIGS. 32-34, the base 318 for use with the lowersupport member 300 preferably contains slots 340 in positions whichcorrespond to the positions of the tabs 320 on the lower support member300. As mentioned above, the base 318 and lower support member 300 maybe manufactured as a single piece using injection molding or an othermanufacturing process known in the art. When manufactured as a singlepiece, the lower support member 300 and base 318 are preferablyconnected by a thin leash of material 310, visible in FIGS. 32 and 34.This thin leash 310 may be broken or cut in order to separate the lowersupport member 300 from the base 318 prior to assembly. Desirably, theentire leash 310 is removed so that there is no stub of materialprojecting from the side of either the lower support member 300 or thebase 318 of the retainer when it is in use upon a patient.

The base 318 as shown in FIGS. 32-34 also provides generally the samefeatures as those discussed with respect to the base 18 shown in FIGS.5-7 above. In particular, the base 318 provides a groove (not visible)on the underside of the base, as well as post openings. The postopenings, as shown in FIG. 32, need not have a circular region, butrather only an elongated track 50. The elongated track 50 may contain ascalloped edge as described above in order to provide positions intowhich the posts may snap, or may have straight sides as shown in FIG.32. It is also shown that the covers 20, 22 may be integrally moldedwith the base 318, as is described with respect to the base 18 in FIGS.5-7 above.

After the base 318 and lower support member 300 are separated, anappropriate pair of posts 250 or a post platform may be inserted intoposition from the underside of the base 318. One post desirably extendsthrough each of the elongated tracks 50 in the bottom of the base 318when the platform or posts are inserted into the base 318. If a postplatform with an attachment button is used, the attachment button isdesirably inserted through the central circular opening 44 on the bottomof the base. The post platform may be as described above, or a pair ofindividual free standing posts 250 as shown in FIG. 25 may be used. Ineither case, it is desirable that the bottom of the platform of theposts lie within the groove of the base 318.

Once the post platform or posts 250 are in position, the lower supportmember 300 is pressed onto the bottom of the base 318 of the retainerand desirably secured in position. In the embodiment shown in FIGS.32-34, the tabs 320 of the lower support member 300 will be insertedinto the corresponding slots 340 in the bottom of the base. Thechamfered tangs of the tabs 320 desirably cause each tab 320 to deflectas the tang passes through the slot 340, and then snap back toward itsoriginal position once the tang is beyond the slot 340 and within theinterior space of the base 318. In this way, the interaction between thetabs 320 and the slot 340 and walls of the base 318 may secure the lowersupport member 300 upon the base 318.

The lower support member 300 may also be secured to the base 318 viaadhesive. This may be used as an alternative to the use of tabs 320 andslots 340, or may be used in addition to the tabs 320 and slots 340 toprovide improved securement between the lower support member 300 and thebase 318. Desirably, when adhesive is used with any embodiment usingposts which move, either as independent posts 250, or as in a postplatform with connectors as shown in FIGS. 11A-11C, any adhesive used ispreferably placed on a portion of the base 318 such that it does notinterfere with the free motion of the posts within the groove of thebase 318. Those of skill in the art will recognize that other means mayalso be used to attach the lower support member 300 to the bottom of thebase 318. For instance, the lower support member 300 may be secured tothe base 318 by ultrasonic welding.

Once assembled as described above, the retainer provides a pair ofT-shaped tracks, similar to those described above with reference to FIG.24, comprised of the groove of the base, and each post opening 50. Theposts are free to move within these grooves as described above in orderto accommodate medical articles of varying dimensions andconfigurations. The usage of the anchoring system formed using the lowersupport member 300 and base 318 shown in FIGS. 32-34 is substantiallythe same as that described with respect to FIGS. 5-7 above.

The various embodiments of anchoring systems and techniques describedabove in accordance with present invention thus provide a sterile,tight-gripping, needle- and tape-free way to anchor a medical article toa patient. The retainer thus eliminates use of tape, and if priorprotocol required suturing, it also reduces the risk of accidentalneedle sticks, suture-wound-site infections and scarring. In addition,the techniques for the described retainers can be used with any of awide variety of catheters, fittings, tubes, wires, and other medicalarticles. Patient comfort is also enhanced and application time isdecreased with the use of the present anchoring system.

Of course, it is to be understood that not necessarily all such objectsor advantages may be achieved in accordance with any particularembodiment of the invention. Thus, for example, those skilled in the artwill recognize that the invention may be embodied or carried out in amanner that achieves or optimizes one advantage or group of advantagesas taught herein without necessarily achieving other objects oradvantages as may be taught or suggested herein.

Furthermore, the skilled artisan will recognize the interchangeabilityof various features from different embodiments. For example, thescalloped edge of the elongated tracks may be adapted for use with thelower support member design shown in FIGS. 32-34. Similarly, the variousbases, covers, posts, slots, hinges, anchor pads, post platforms, lowersupport members and latching mechanisms disclosed herein, as well asother known equivalents for each such feature, can be mixed and matchedby one of ordinary skill in this art to construct anchoring systems inaccordance with principles of the present invention.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it therefore will be understood bythose skilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. Thus, it is intended that the scope of the present inventionherein disclosed should not be limited by the particular disclosedembodiments described above, but should be determined only by a fairreading of the claims that follow.

1-4. (canceled)
 5. The retainer of claim 49 additionally comprising apost, wherein the post is movably coupled to the base member. 6.-48.(canceled)
 49. A securement device for securing a medical article to apatient, the medical article having an elongated body with a pair oflateral wings, comprising: an adhesive bottom layer for attaching to theskin of a patient; a base member disposed above the adhesive bottomlayer; and a first cover member and a second cover member being arrangedgenerally in a side-by-side relationship with a gap existing between thecover members, each cover member cooperating with the base member todefine a space of sufficient size to receive a wing of the medicalarticle with at least a portion of the elongated body being disposedgenerally within the gap.
 50. The securement device of claim 49, whereinthe first and second cover members move less than 180 degrees between aclosed position and an open position.
 51. The securement device of claim49, wherein the first and second cover members have lateral lengths suchthat at least portions of the covers do not interact with each other atleast when the medical article is secured within the securement deviceand the covers are closed.
 52. The securement device of claim 49,wherein each of the first and second cover members includes a skirt thatextends about the base member, the skirts interacting with the medicalarticle so as to inhibit movement of the medical article in at least alongitudinal direction relative to the securement device.
 53. Thesecurement device of claim 49, wherein the gap is sized to receive abulky central portion of the elongated body of the medical article. 54.A securement device for securing a medical article which has a pair oflaterally extending wings, to the body of a patient, comprising: anadhesive to attach the securement device to the body of the patient; alower member disposed above the adhesive; and a cover assembly disposedabove the lower member, the cover assembly including two covers, eachcover being connected to the base and having at least two positions, afirst position and a second position, at least a portion of each wingbeing disposed between the cover assembly and the base at least when themedical article is secured within the retainer and the two covers are inthe second position, the covers having a lateral length such that atleast portions of the covers do not interact with each other at leastwhen the medical article is secured within the securement device and thetwo covers are in the second position.
 55. The securement device ofclaim 54 further comprising flexible couplings between the coverassembly and the lower member.
 56. The securement device of claim 54,wherein the covers move less than 180 degrees between the first andsecond positions.
 57. The securement device of claim 54 furthercomprising a skirt extending about the base so as to inhibit movement ofthe secured medical article relative to the securement device in atleast one direction.
 58. The securement device of claim 57, wherein theskirt extends from the cover in at least a transverse directiongenerally toward the lower member so as to inhibit longitudinal movementof the secured medical article relative to the securement device. 59.The securement device of claim 54 further comprising a flange attachedto the cover, the flange facilitating movement of the cover relative tothe lower member.
 60. The securement device of claim 54, wherein thelower member is rigid.
 61. A securement device for securing a medicalarticle having a pair of laterally extending wings to a patient,comprising: a first portion and a second portion disposed on the firstportion, at least two parts of the second portion generally opposingeach other and being spaced apart to define a gap therebetween, the twoparts of the second portion being movable relative to the first portionso as to receive a pair of wings between the first and second portionswith a portion of the medical article being positioned in the gap, thetwo parts of the second portion being independently movable relative toeach other, and the second portion extending over and about at least aportion of both wings when the wings are received between the first andsecond portions.
 62. The securement device of claim 61 furthercomprising an adhesive to attach the securement device to a body of thepatient, and wherein the first portion is a base and the second portionis a cover assembly.
 63. The securement device of claim 61, wherein thesecond portion comprises a skirt, the skirt extending about the wings soas to inhibit longitudinal movement of the secured medical article in atleast one direction relative to the securement device.
 64. Thesecurement device of claim 63, wherein the skirt extends in at least atransverse direction generally toward the first portion so as to inhibitlongitudinal movement of the secured medical article relative to thesecurement device.
 65. The securement device of claim 61 furthercomprising a flange attached to the second portion, the flangefacilitating movement of the second portion relative to the firstportion.
 66. A securement system comprising: a medical article having acentral portion and two wings extending in a opposite lateral directionstherefrom, the central portion having a transverse height greater than atransverse height of the two wings; an adhesive to attach the securementdevice to the body of the patient; and a lower member disposed above theadhesive; and a cover assembly disposed above the lower member andincluding two covers, the covers having lateral lengths such that a gapis formed between the covers at least when the medical article issecured within the securement device and the covers are in a closedposition, the covers being disposed at a transverse height that isgreater than the transverse height of the two wings and less than thetransverse height of the central portion of the medical article at leastwhen the medical article is secured within the securement device and thecovers are in the closed position so that at least a portion of thecentral portion of the medical article is disposed in the gap.
 67. Thesecurement system of claim 66 further comprising skirts, the skirtsdefining a receiving space on the retainer, and wherein the two coversare arranged over the lower member so as to cover at least a portion ofthe receiving space when in the closed position, and wherein a firstportion of the receiving space receives at least a portion of one of thewings and a second portion of the receiving space receives at least aportion of the other wing.